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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K935655
Device Name ABL5 BLOOD GAS SYSTEM
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Correspondent Contact DONALD L BAKER
Regulation Number862.1120
Classification Product Code
CHL  
Date Received11/24/1993
Decision Date 05/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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